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Generated: August 21, 2018

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Norethindrone - Generic Drug Details

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What are the generic drug sources for norethindrone and what is the scope of norethindrone patent protection?

Norethindrone is the generic ingredient in twelve branded drugs marketed by Parke Davis, Mayne Pharma, Glenmark Generics, Aurobindo Pharma Ltd, Lupin Ltd, Janssen Pharms, Apil, Accord Hlthcare, Amneal Pharms, Mylan Labs Ltd, Novast Labs, Novast Labs Ltd, Duramed Res, and Barr, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for norethindrone. Nineteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Pharmacology for norethindrone
Ingredient-typeProgesterone Congeners
Drug ClassProgestin
Medical Subject Heading (MeSH) Categories for norethindrone
Synonyms for norethindrone
(17-alpha)-17-Hydroxy-19-norpregn-4-en-20-yn-3-one
(17alpha)-17-ethynyl-17-hydroxyestra-4,8(14),9-trien-3-one
(17alpha)-17-hydroxy-19-norpregn-4-en-20-yn-3-one
(17beta)-17-ethynyl-17-hydroxyestr-4-en-3-one
(1S,2R,10R,11S,14R,15S)-14-ethynyl-14-hydroxy-15-methyltetracyclo[8.7.0.0?,?.0??,??]heptadec-6-en-5-one
(1S,2R,10R,11S,14R,15S)-14-ETHYNYL-14-HYDROXY-15-METHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-5-ONE
(8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one
(8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one
(8R,9S,10R,13S,14S,17R)-17-Ethynyl-17-hydroxy-13-methyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one
067N596
13-methyl-17alpha-ethynyl-17-hydroxygon-4-en-3-one
17-alpha-19-Norpregn-4-en-20-yn-3-one, 17-hydroxy-
17-alpha-Ethinyl-17-beta-hydroxy-delta(sup:4)-estren-3-one
17-alpha-Ethinylestra-4-en-17-beta-ol-3-one
17-alpha-Ethynyl-17-beta-hydroxy-19-norandrost-4-en-3-one
17-alpha-Ethynyl-17-beta-hydroxy-4-estren-3-one
17-alpha-Ethynyl-17-hydroxy-4-estren-3-one
17-alpha-Ethynyl-19-norandrost-4-en-17-beta-ol-3-one
17-alpha-Ethynyl-19-nortestosterone
17-alpha-Ethynyl-4-estren-17-ol-3-one
17-beta-Hydroxy-19-norpregn-4-en-20-yn-3-one
17-Ethinyl-19-nor-testosterone
17-Ethinyl-19-nortestosterone
17-Ethynyl-17-hydroxyestr-4-en-3-one
17-Ethynyl-17-hydroxyestr-4-en-3-one (ACD/Name 4.0)
17-ethynyl-17beta-hydroxyestr-4-en-3-one
17-Ethynyl-19-Nortestosterone
17-Hydroxy-(17alpha)-19-Norpregn-4-en-20-yn-3-one
17-Hydroxy-17-alpha-19-norpregn-4-en-20-yn-3-one
17-Hydroxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one
17-Hydroxy-19-nor-17alpha-4-pregnen-20-yn-3-one
17-Hydroxy-19-nor-17alpha-pregn-4-en-20-yn-3-one
17-hydroxy-19-nor-17alpha-pregn-4-en-20yn-3-one
17.alpha.-Ethinyl-19-nortestosterone
17.alpha.-Ethynyl-19-nortestosterone
17.alpha.-Ethynyl-4-estren-17-ol-3-one
17alpha-Ethinyl-17alpha-Ethinyl-19-nortestosterone
17alpha-Ethinyl-17beta-hydroxy-delta(sup:4)-estren-3-one
17alpha-Ethinyl-19-nortestosterone
17alpha-Ethinylestra-4-en-17beta-ol-3-one
17alpha-Ethynyl-17 beta-hydroxy-19-nor-4-androsten-3-one
17alpha-Ethynyl-17-hydroxy-4-estren-3-one
17alpha-ethynyl-17-hydroxy-Estr-4-en-3-one
17alpha-Ethynyl-17-hydroxyest-4-en-3-one
17alpha-Ethynyl-17beta-hydroxy-19-nor-4-androsten-3-one
17alpha-Ethynyl-17beta-hydroxy-19-norandrost-4-en-3-one
17alpha-Ethynyl-17beta-hydroxyestr-4-en-3-one
17alpha-Ethynyl-19-nor-4-androsten-17beta-ol-3-one
17alpha-Ethynyl-19-norandrost-4-en-17beta-ol-3-one
17alpha-Ethynyl-19-nortestosterone
17alpha-Ethynyl-3-oxo-4-estren-17beta-ol
17alpha-Ethynyl-4-estren-17-ol-3-one
17alpha-hydroxy-19-norpregn-4-en-20-yn-3-one
17alpha-pregn-4-en-20-yn-3-one
17beta-Hydroxy-17alpha-ethynylestr-4-en-3-one
17beta-Hydroxy-19-norpregn-4-en-20-yn-3-one
19-Nor-17-alpha-ethynyl-17-beta-hydroxy-4-androsten-3-one
19-Nor-17-alpha-ethynylandrosten-17-beta-ol-3-one
19-Nor-17-alpha-ethynyltestosterone
19-Nor-17-alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-
19-Nor-17-ethinyl testosterone
19-Nor-17-ethinyltestosterone
19-Nor-17.alpha.-ethynyltestosterone
19-Nor-17alpa-ethynyltestosterone
19-Nor-17alpha-ethynyl-17beta-hydroxy-4-androsten-3-one
19-Nor-17alpha-ethynyl-4-androsten-17beta-ol-3-one
19-nor-17alpha-Ethynylandrosten-17beta-ol-3-one
19-Nor-17alpha-ethynyltestosterone
19-Nor-17alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-
19-Nor-17alpha-pregn-4-en-20-yn-3-one, 17-hydroxy- (8CI)
19-Nor-ethindrone
19-Nor-ethinyl--4,5-testosterone
19-Nor-ethinyl-4,5-testosterone
19-Norethindrone
19-Norethindrone, >=98%, powder
19-Norethindrone, VETRANAL(TM), analytical standard
19-Norethinyltestosterone
19-Norethisterone
19-Norpregn-4-en-20-yn-3-one, 17-hydroxy-, (17alpha)-
19-Norpregn-4-en-20-yn-3-one,17-hydroxy-, (17a)-
19-Nortestosterone, 17-ethynyl-
3B1-007314
4-Estren-17alpha-ethynyl-17beta-ol-3-one
68-22-4
AC-11100
AC1L1M2R
Activella
AI3-26422
AK307564
AKOS005267172
AN-829
Anhydrohydroxynorprogesterone
Anovulatorio
Anovule
ARONIS24281
BB_NC-0600
BBC/437
BDBM50148732
BPBio1_000074
BRD-K92073408-001-03-3
Brevicon
Brevinor
Brevinor 21
Brevinor 28
Brevinor-1 21
Brevinor-1 28
BRN 1915671
BSPBio_000066
C05028
Camila
Camila (TN)
CAS-68-22-4
CCG-220253
CCRIS 484
CHEBI:7627
CHEMBL1162
Ciclovulan
CJ-22223
component of Noriday
Conceplan
Conludaf
Conludag
CPD000499579
CS-2664
D00182
D0GL7U
DB00717
Demulen
DSSTox_CID_3380
DSSTox_GSID_23380
DSSTox_RID_77005
DTXSID9023380
EINECS 200-681-6
ENT
Errin
Estr-4-en-3-one, 17alpha-ethynyl-17-hydroxy-
Estrinor
Ethinyl-19-nortestosterone
Ethinylnortestosterone
Ethynylmortestosterone
Ethynylnortestosterone
Gencept
Genora
Gestest
GTPL2880
HMS1568D08
HMS2090D21
HMS2095D08
HMS2231E18
HMS3259C16
HSDB 3370
HY-B0554
Jenest
Jenest-28
KS-000048I5
LMST02030097
Loestrin
LS-97425
MCULE-9156628994
Menzol
MFCD00067596
Microneth
Micronett
Micronor
Micronor (TN)
Micronovum
Milli
Mini-Pe
Mini-pill
Minovlar
MLS001076679
MLS001163874
MolPort-002-507-131
N.E.E
N.E.E.
N0449
NC00576
NCGC00094738-01
NCGC00179669-01
NCGC00179669-02
NCGC00179669-04
NCGC00255187-01
Nelova
NET
Nodiol
Nor-Q.D
Nor-Q.D.
Nor-QD
Nora-BE
Noraethisteronum
Noralutin
Norcept
Norcept-E
Norcolut
Norcolute
Noresthisterone
Norethadrone
Norethin
Norethin 1/35 E
Norethin 1/50 M
Norethindirone
Norethindrone (Norethisterone)
Norethindrone (Norethisterone), pharmaceutical secondary standard; traceable to USP, PhEur, BP
Norethindrone (USP)
Norethindrone [USAN]
Norethindrone [USP]
Norethindrone Norethisterone
Norethindrone, United States Pharmacopeia (USP) Reference Standard
Norethisteron
Norethisterone
Norethisterone (JP15)
Norethisterone (JP17)
norethisterone (norethindrone)
Norethisterone [Progestins]
Norethisterone for system suitability, European Pharmacopoeia (EP) Reference Standard
Norethisterone, European Pharmacopoeia (EP) Reference Standard
Norethisteronum
Norethisteronum [INN-Latin]
Norethyndron
Norethynodron
Norethynodrone
Noretisterona
Noretisterona [INN-Spanish]
Noretisterone
Noretisterone [DCIT]
Norfor
Norgestin
Noriday
Noriday 28
Norluten
Norlutin
Norluton
Normapause
Norpregneninlone
Norpregneninolone
Norpregneninotone
NSC-9564
Orlest
Ortho 1 35
Ortho 7 7 7
Ortho-novum
Ortho-Novum 1 35
Ortho-Novum 1 50
Ortho-Novum 7 7 7
Ovcon
Ovysmen 0.5 35
Ovysmen 1 35
PL039325
Prestwick_646
Prestwick0_000253
Prestwick1_000253
Prestwick2_000253
Prestwick3_000253
Primolut N
Primolut-N
Primolut-N (TN)
Proluteasi
RP17635
s4040
SC 4640
SC-16223
SCHEMBL23390
SMR000499579
SPBio_002285
SR-01000765382
SR-01000765382-3
Synphase
Synphasic 28
T18F433X4S
Tox21_111322
Tox21_111322_1
Tox21_302427
Tri-Norinyl
Triella
Trinovum 21
UNII-T18F433X4S
Utovlan
Utovlar
VIKNJXKGJWUCNN-XGXHKTLJSA-N
W-104686
ZINC85205451
Tentative approvals for NORETHINDRONE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial1MG;0.01MG;75MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial1MG;0.02MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial75MGTABLET;ORAL

US Patents and Regulatory Information for norethindrone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd NORETHINDRONE norethindrone TABLET;ORAL-28 091325-001 Sep 19, 2011 AB1 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Barr NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 075951-001 May 25, 2001 AB RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd INCASSIA norethindrone TABLET;ORAL-28 207304-001 Sep 23, 2016 AB1 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Parke Davis NORLUTATE norethindrone acetate TABLET;ORAL 012184-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lupin Ltd JENCYCLA norethindrone TABLET;ORAL-28 091323-001 Mar 28, 2013 AB2 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Duramed Res AYGESTIN norethindrone acetate TABLET;ORAL 018405-001 Apr 21, 1982 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Mallinckrodt
US Department of Justice
Colorcon
Daiichi Sankyo
Queensland Health
Cipla
Accenture
McKinsey

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